Cleared Traditional

RCNG: ROOT CANAL NEGOTIATING GEL (K992484) - FDA 510(k) Clearance

Also marketed or referenced as:
MODEL RCNG
K992484 · Jordco, Inc. · Dental device
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Oct 1999
Decision
80d
Days
-
Risk

K992484 is an FDA 510(k) clearance for the RCNG: ROOT CANAL NEGOTIATING GEL. Classified as Cleanser, Root Canal (product code KJJ).

Submitted by Jordco, Inc. (Beaverton, US). The FDA issued a Cleared decision on October 14, 1999 after a review of 80 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Jordco, Inc. devices

Submission Details

510(k) Number K992484 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 1999
Decision Date October 14, 1999
Days to Decision 80 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 127d · This submission: 80d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KJJ Cleanser, Root Canal
Device Class -